BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032375 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02324
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CATHETER DISLODGED AND HAD PULLED OUT OF THE INTRATHECAL SPACE. ON (B)(6) 2011 THE CATHETER WAS REVISED. THE PUMP CONTAINED LIORESAL. THE DRUG CONCENTRATION WAS CHANGED FROM 2000 MCG/ML TO 500 MCG/ML FOLLOWING THE REVISION. A BRIDGE BOLUS WAS PROGRAMMED WITH THE OLD DRUG DESIRED DOSE OF 100 MCG/DAY. ON (B)(6) 2011, THE PATIENT WAS "VERY SPASTIC," THEREFORE, THE BRIDGE BOLUS WAS CANCELED AND THE PUMP WAS REPROGRAMMED WITH A PRIME BOLUS TO SIMULATE THE BRIDGE BOLUS. THE PRIME BOLUS WOULD DELIVER 150 MCG/DAY. THE PATIENT'S OUTCOME FOLLOWING THIS INTERVENTION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N229064004| IMPLANTED: